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Study of HPN424 in Patients With Advanced Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03577028
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Harpoon Therapeutics

Brief Summary:
An open-label, Phase 1, study of HPN424 as monotherapy to assess the safety, tolerability and PK in patients with advanced prostate cancer refractory to androgen therapy

Condition or disease Intervention/treatment Phase
Advanced Prostate Cancer Biological: HPN424 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN424 in Patients With Advanced Prostate Cancer Refractory to Androgen Therapy
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Experimental: HPN424-1001

In Part 1 (Dose Escalation), HPN424 will be administered once weekly via IV infusion with dose escalation until an estimated therapeutic dose level has been reached.

In Part 2 (Dose Expansion), patients will receive HPN424 at the recommended phase 2 dose(s) established in Part 1 of the study. Study procedures will be the same in Part 1 and Part 2 of the study. Additional expansion cohorts of up to 18 patients per expansion cohort may be added.

Biological: HPN424
In Part 1 (Dose Escalation), HPN424 will be administered once weekly via IV infusion. In Part 2 (Dose Expansion), HPN424 will be administered at the recommended phase 2 dose(s) once weekly via IV infusion.




Primary Outcome Measures :
  1. Incidence of dose limiting toxicities [ Time Frame: Up to study day 21 ]
    In Part 1, measure incidence of dose limiting toxicities measured by adverse events and serious adverse events by dose level.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Male patients ≥18 years of age
  2. Histologically or cytologically confirmed adenocarcinoma of the prostate
  3. Progressive metastatic castrate-resistant prostate cancer (mCRPC): a) serum testosterone levels less than 50 ng/dL (or ≤0.50 ng/mL or 1.73 nmol/L) within 28 days prior to start of study drug, b) radiographic evidence of metastatic disease and c) disease progression on the prior systemic regimen,
  4. Must have received at least 2 prior systemic therapies approved for mCRPC
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. Adequate bone marrow function, including:
  7. Able to read, understand and provide written informed consent

Key Exclusion Criteria:

  1. Untreated brain metastases. Participants must have completed treatment for brain metastasis, and be neurologically stable off steroids, for at least 4 weeks prior to first dose of study drug.
  2. Untreated spinal cord compression. Participants must be neurologically stable off steroids for at least 4 weeks prior to first dose of study drug.
  3. Concurrent treatment with anti-tumor necrosis factor (TNF) alpha therapies, systemic corticosteroids (prednisone dose >10 mg per day or equivalent), or other immune suppressive drugs within the 2 weeks prior to Screening
  4. History of or known or suspected autoimmune disease (exception(s): patients with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at Screening are allowed)
  5. History of clinically significant cardiovascular disease
  6. Active or chronic hepatitis B or hepatitis C as demonstrated by hepatitis B surface antigen (HBsAg) positivity and/or anti-hepatitis C virus (HCV) positivity, respectively, or known history of human immunodeficiency virus (HIV) seropositive status
  7. Clinically active or chronic liver disease,
  8. Second primary malignancy that has not been in remission for greater than 3 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577028


Contacts
Contact: Harpoon Therapeutics 1-650-689-1047 HPN4241001@harpoontx.com

Locations
United States, New York
New York Presbyterian Hospital-Columbia University Medical Center. Recruiting
New York, New York, United States, 10032
Contact: Bridget James    212-304-5543      
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Sarah Cannon Research Institute         
Contact    1-844-482-4812      
Sponsors and Collaborators
Harpoon Therapeutics

Responsible Party: Harpoon Therapeutics
ClinicalTrials.gov Identifier: NCT03577028     History of Changes
Other Study ID Numbers: HPN424-1001
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases